Resuscitation Failure, Oxidative Stress, and Necroptosis as Mortality Predictor in Septic Patient

NCT04169412 | Completed DMC

• 1 other identifier: 047/kepkrsmhfkunsri/2019
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Resuscitation failure, oxidative stress and necroptosis were able to predict mortality in septic patient

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• The Ability of Resuscitation Failure, Protein Carbonyl (PCO) and Receptor Interacting Protein Kinase 3 (RIPK3) for Predicting Mortality in Septic Patients

  Probability of Mortality in Septic Patients with Resuscitation Failure, High PCO Level and High RIPK3 Level

  28 days

Secondary Outcomes (2)

• How Sensitive and Specific Protein Carbonyl (PCO) Level for Predicting Mortality in Septic Patients?

  28 days

• How Sensitive and Specific Receptor Interacting Protein Kinase 3 (RIPK3) Level for Predicting Mortality in Septic Patients?

  28 days

Study Arms (2)

Resuscitation Failure, High PCO Level, High RIPK3 Level

1. Resuscitation failure was defined as lactate level ≥2 mmol/L or lactate reduction \<20% hour-4 after initial sepsis recognition. 2. High PCO level was defined as PCO level ≥ cut off point. 3. High RIPK3 level was defined as PCO level ≥ cut off point.

Diagnostic Test: Blood Collection

Resuscitation Success, Low PCO Level, Low RIPK3 Level

1. Resuscitation success was defined as lactate level \<2 mmol/L or lactate reduction ≥20% hour-4 after initial sepsis recognition. 2. Low PCO level was defined as PCO level \< cut off point. 3. Low RIPK3 level was defined as PCO level \< cut off point.

Diagnostic Test: Blood Collection

Interventions

Blood Collection DIAGNOSTIC_TEST

Blood Gas Analysis using Stat Profile pHOx® Series (nova biomedical, Waltham, U.S.) and Enzym-linked Immunosorbent Assay (ELISA) using Bio-Rad (Bio-Rad Laboratories, California, U.S.)

Resuscitation Failure, High PCO Level, High RIPK3 Level; Resuscitation Success, Low PCO Level, Low RIPK3 Level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Resuscitation room and ICU

You may qualify if:

• Participants aged 18 years old or above
• Diagnosed sepsis using Sepsis-3 definition

You may not qualify if:

• Participants whose family did not give any consent to participate
• Not treated at the ICU
• Had a late diagnosis (\>24 h)
• Pregnant
• Brain dead

Sponsors & Collaborators

• Universitas Sriwijaya: lead
• Indonesia University: collaborator

Study Sites (1)

Mohammad Hoesin Central General Hospital

Palembang, South Sumatera, 30126, Indonesia

Location

Related Publications (29)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 19, 2019
• Study Start: February 22, 2019
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

ID (1)